510(k) · Cleared
ClearedEsensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System, Model 4800
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Micro Sensors · NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Cleared on Jan 19, 2006 as substantially equivalent to DEN050004 (Tm Bioscience Corporation, 2005) after a 232-day review. Its family tree reaches back 1 generation to 2005. 3 later devices descend from it.
- Decided
- Jan 19, 2006
- Review
- 232 days
- Class
- Class II
- Product code
- NUA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to DEN050004 (2005). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN050004 Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 2005
- This deviceK051435 Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna…Clinical Micro Sensors · 2006
- Descendant · cites it directly · 2 of its ownK060543 Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800Clinical Micro Sensors, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK090901 Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis…Osmetech Molecular Diagnostics · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK093974 Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test…Osmetech Molecular Diagnostics · 2010
Most influential descendants
Showing 3 of 3 · See all- K060543Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800Clinical Micro Sensors, Inc. · 2006 · cites it directly2descendants
- K090901Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test…Osmetech Molecular Diagnostics · 2009 · cites it directly1descendant
- K093974Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test, Esenor Fii GenotypingOsmetech Molecular Diagnostics · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN050004 | Tag-IT Cystic Fibrosis Kit | Tm Bioscience Corporation | 2005 | — |
| 0 (this device) | K051435 | Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection… | Clinical Micro Sensors | 2006 | — |
| +1 | K060543 | Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800 | Clinical Micro Sensors, Inc. | 2006 | — |
| +1 | K090901 | Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping… | Osmetech Molecular Diagnostics | 2009 | 2 |
| +2 | K093974 | Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test, Esenor Fii… | Osmetech Molecular Diagnostics | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NUA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN050004 | Tag-IT Cystic Fibrosis Kit Our reading of the summary gave K043011, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN050004, Tag-IT Cystic Fibrosis Kit (Tm Bioscience Corporation), granted May 9, 2005; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2005 |
| Kept off the family tree | K003664 | FDA’s K003664 is Delfia Neonatal Irt Kit, Model A005-110 Our reading of the summary gave K003664, FDA’s number for Delfia Neonatal Irt Kit, Model A005-110 (Wallac OY). Its FDA name has none of the distinctive words the summary uses for the device it names, “Affymetrix GeneChip® Microarray Instrumentation System”. Kept off the family tree. Summary page 2…ection System is equivalent to the Tm Bioscience Tag-It TM Cystic Fibrosis Kit 510(k) K04301 1, and to the Affymetrix GeneChip® Microarray Instrumentation System 5 10(k) K003664. Page 14-2 of 14-5… | 2001 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All NUA devicesNUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NUA
2in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · NUA
254in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUA
No recall names NUA since 2007.
Adverse event reports per year · NUA
1in 2013
MAUDE reports naming product code NUA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 4 | 254 | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The eSensor® Cystic Fibrosis Carrier Detection System is a device for the detection of carrier status for cystic fibrosis for all adult couples contemplating pregnancy, regardless of ethnicity. It is a qualitative genotyping assay that simultaneously detects mutations currently recommended by the American College of Medical Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG). The eSensor® CFCD System is not indicated for prenatal screening or to establish a diagnosis of cystic fibrosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051435 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051435: Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System, Model 4800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051435
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026